ISRCTN73554751
Completed
Not Applicable
A feasibility study for a randomised controlled trial to measure the impact of frenotomy in breastfed infants with tongue tie
Southmead Hospital (UK)0 sites100 target enrollmentOctober 20, 2011
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Southmead Hospital (UK)
- Enrollment
- 100
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Term born infants with a functionally significant tongue tie (Hazelbaker Assessment Tool for Lingual Frenulum Function \[HATLFF] score between 6\-12\) with breast feeding difficulties (LATCH score \<\-8\)
- •2\. Male and female participants
- •3\. Upper Age Limit is 14 days
Exclusion Criteria
- •1\. Preterm infants
- •2\. Infants with serious congenital anomalies
- •3\. Infants who have lost \>10% of their birth weight unless found to be well enough after checking by a neonatologist
- •4\. Infants with a HATLFF score of \<6, and those over 2 weeks old will be excluded from the study
- •5\. Mothers who do not want their baby to have surgery
- •6\. Babies that have not received vitamin K soon after birth, unless the mother agrees to an injection of vitamin K one hour before entering the trial
Outcomes
Primary Outcomes
Not specified
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